Back to resultsCasein Glycomacropeptide in Healthy Subjects
Primary Purpose
Gastrointestinal Disease
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Casein glycomacropeptide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Gastrointestinal Disease focused on measuring glycopeptides, dietary proteins, whey protein, caseinomacropeptide, antiinflammatories, human microbiome
Eligibility Criteria
Inclusion Criteria:
- Caucasians
- Body Mass Index 18.5-25.0
Exclusion Criteria:
- Within 3 months: Acute intestinal disease (diarrhea more than 3 days in a week or bloody stools), hospital admission or antibiotic treatment.
- Chronic inflammatory disease or intestinal disease, including Crohn's disease, ulcerative colitis, celiac disease, rheumatoid arthritis or any other autoimmune joint disease, multiple sclerosis or any intestinal surgery apart from appendectomy.
- Pregnant or nursing.
- Unable to speak and understand Danish.
Sites / Locations
- Department of medicine V (Hepatology and Gastroenterology)
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Casein glycomacropeptide (CGMP)
Placebo
Arm Description
During 4 weeks a daily oral intake of CGMP-protein-shake.
During 4 weeks a daily oral intake of placebo-shake consisting of milk powder.
Outcomes
Primary Outcome Measures
Number of participants with changes in systemic inflammation markers and cellular immune response
C-reactive protein, leukocyte count
Secondary Outcome Measures
Number of participants with changes in the intestinal microbiome
alfa- and beta-diversity
Number of participants with changes in gastrointestinal symptoms
questionnaire
Full Information
NCT ID
NCT02832700
First Posted
June 30, 2016
Last Updated
June 6, 2019
Sponsor
University of Aarhus
Collaborators
Arla Foods
1. Study Identification
Unique Protocol Identification Number
NCT02832700
Brief Title
Casein Glycomacropeptide in Healthy Subjects
Official Title
Casein Glycomacropeptide in Healthy Subjects - Anti-inflammatory and Microbiome Modulating Effects
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
September 1, 2017 (Actual)
Study Completion Date
September 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Arla Foods
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Casein glycomacropeptide (CGMP) has anti-inflammatory properties in experimental rodent colitis and using human in vitro inflammation models. Its use as a food ingredient has proven safe and with no influence on dietary intake. In a pilot study the investigators found, that orally administered CGMP seems to have a beneficial effect comparable to that of mesalazine in active distal ulcerative colitis.
The investigators now wish to evaluate the effects in healthy subjects by studying the anti-inflammatory and microbiome modulating properties and by assessing possible changes in gastrointestinal symptoms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Disease
Keywords
glycopeptides, dietary proteins, whey protein, caseinomacropeptide, antiinflammatories, human microbiome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Casein glycomacropeptide (CGMP)
Arm Type
Active Comparator
Arm Description
During 4 weeks a daily oral intake of CGMP-protein-shake.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
During 4 weeks a daily oral intake of placebo-shake consisting of milk powder.
Intervention Type
Dietary Supplement
Intervention Name(s)
Casein glycomacropeptide
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Number of participants with changes in systemic inflammation markers and cellular immune response
Description
C-reactive protein, leukocyte count
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Number of participants with changes in the intestinal microbiome
Description
alfa- and beta-diversity
Time Frame
4 weeks
Title
Number of participants with changes in gastrointestinal symptoms
Description
questionnaire
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
Compliance
Description
Number of participants with an average daily intake of above 75% of the intervention-product
Time Frame
4 weeks
Title
Intestinal butyrate production
Description
Number of participants with increase in daily butyrate-production
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Caucasians
Body Mass Index 18.5-25.0
Exclusion Criteria:
Within 3 months: Acute intestinal disease (diarrhea more than 3 days in a week or bloody stools), hospital admission or antibiotic treatment.
Chronic inflammatory disease or intestinal disease, including Crohn's disease, ulcerative colitis, celiac disease, rheumatoid arthritis or any other autoimmune joint disease, multiple sclerosis or any intestinal surgery apart from appendectomy.
Pregnant or nursing.
Unable to speak and understand Danish.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hendrik A Vilstrup, Professor
Organizational Affiliation
University of Aarhus
Official's Role
Study Chair
Facility Information:
Facility Name
Department of medicine V (Hepatology and Gastroenterology)
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
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Casein Glycomacropeptide in Healthy Subjects
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